BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

    MDR report key: 16154380 · Received January 12, 2023

    Report

    Report Number
    1423507-2023-00040
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    June 28, 2022
    Report Date
    January 27, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    FQH
    UDI-DI
    00382909101003
    PMA / PMN Number
    K202071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRO CODES: FQH (LAVAGE, JET) AND FRO (DRESSING, WOUND, DRUG). NO PHOTOS OR PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION; THEREFORE, THE INCIDENT COULD NOT BE VERIFIED. THE REPORTED LOT'S (1854588) DEVICE HISTORY RECORDS WERE REVIEWED. ALL PROCESS AND FINAL INSPECTIONS MEET SPECIFICATIONS. AN IN-DEPTH INVESTIGATION AS PART OF THAT CAPA HAS BEEN PERFORMED TO IDENTIFY THE CAUSE OF THE SURGIPHOR BOTTLE CRACKING DURING USE. AT THIS TIME THIS INVESTIGATION DISCOVERED THAT THE COMBINATION OF THE FOLLOWING VARIABLES ARE PROBABLE CAUSES THAT CONTRIBUTE TO THE FAILURE MODE OF SURGIPHOR CONTAINERS CRACKING DURING USE: AGING, BOTTLE WALL THICKNESS/BOTTLE WEIGHT, INSPECTED PRODUCT RETURNED INTO THE MANUFACTURING LOT, AND UPPER END OF THE GAMMA STERILIZATION DOSAGES OF THE PRODUCT. A FOLLOW-UP WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION. SUPPLEMENTAL MDR BEING SUBMITTED FOR DEVICE RETURN TO MANUFACTURER AND DEVICE EVAL BY MANUFACTURER (DEVICE MANUFACTURERS ONLY H) EDITS.

    Description of Event or Problem · 0

    THE SURGIPHOR BOTTLE BUSTED WHEN THE SURGEON SQUEEZED IT. THEY SAID IT WAS DENTED IN WHEN THEY OPENED THE PRODUCT AND THEN WHEN THE SURGEON TRIED TO USE IT, IT SPRAYED EVERYWHERE. BOTTLE WAS BUSTED, BUT IT DID NOT CAUSE ANY PHYSICAL HARM.

    Description of Event or Problem · 0

    THE SURGIPHOR BOTTLE BUSTED WHEN THE SURGEON SQUEEZED IT. THEY SAID IT WAS DENTED IN WHEN THEY OPENED THE PRODUCT AND THEN WHEN THE SURGEON TRIED TO USE IT, IT SPRAYED EVERYWHERE. BOTTLE WAS BUSTED, BUT IT DID NOT CAUSE ANY PHYSICAL HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528839 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM SURGIPHOR FQH CAREFUSION, INC 910100 1854588 00382909101003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown